Case study: The clinical superwoman

作者：郎默 发布时间：2019-03-07 12:03:03

By Jessica Griggs Vinita Gurung works in the obstetrics and gynaecology unit at Nottingham City Hospital. In 2007, while working as a senior house officer – a junior doctor position – she decided to take three years out of her medical training and do a stint as a clinical research fellow. She now splits her time between the two roles. How did you get the clinical research job? I’ve always been fascinated by research, so I half kept an eye on the research jobs coming up. Eventually I saw a poster for a post as a clinical research fellow that I was experienced enough to apply for. What’s more, the project was about a condition called obstetric cholestasis, which I already knew a bit about. The other attraction was that the interviewers wanted the project to be part of a PhD thesis. That suited me as I didn’t want to work for three years with nothing to show for it apart from published papers, so when they offered me the job, I accepted. What was the trial trying to find out? Obstetric cholestasis is a condition where women experience itching during pregnancy, resulting from an inability of the liver to transfer bile to the intestine. There is a build-up of bile salts in the blood which causes the itching. The condition isn’t well understood but it is generally thought to be associated with stillbirth so some doctors induce birth early. However, looking back very carefully at the small amount of data and the few studies that have been done, we found no robust evidence to support this. So we designed a randomised clinical trial to investigate whether the most commonly used drug treatment works, and whether inducing labour early is actually a good idea. We recruited 125 women, and the trial is due to finish in spring this year. What was your role? In the beginning I was involved in all aspects of the trial – I was the trial manager and coordinator, the participants’ doctor and one of two recruiters. Last April, at the end of my three-year fellowship, I went back to my senior house officer role but I have continued to manage and coordinate the trial, fitting it all around my shifts. When all the data is in, I will write it up. It sounds like you were thrown in at the deep end? Yes. It was a really steep learning curve because I really didn’t know how to deal with the clinical role and the managing/coordinating side of things. Plus the research world was new to me. I had to juggle quite a few balls but I think everyone has to when you work on such projects. Can you describe a typical week working on the trial? Every day is different. When I first started, I had to design the trial and work out the best methodology. A lot of my time was spent applying for ethics approval, permission from the NHS trusts involved to actually do the research, and authorisation from the regulatory body the Medicines and Healthcare products Regulatory Agency (MHRA). I also had to review all the existing literature on the condition. All that took 12 months. Once all the paperwork done was done, I had to coordinate the six centres taking part in the trial. My job was to train the principal investigators to recruit and randomise participants and then liaise regularly with them, the pharmacists and the midwives at the centres. Before the trial got underway, I gave presentations so everyone at the hospital was aware that it was going on. Because I was also one of the recruiters, I had other responsibilities. The midwives and doctors would inform me if they had diagnosed a woman with this itching condition. I would go and speak to the woman to see if she was eligible for the trial and keen to participate. If she was, I would recruit and randomise her and after that, it was my responsibility to see her every week until she gave birth and to answer any questions she may have. Is yours a typical route into clinical research for people trained in medicine? There are two routes. People who know that they are interested in clinical research early on in their career can apply to do an academic clinical fellowship as part of their junior doctor training. A significant portion of that time must be used to carry out research. But if you are like me and don’t decide until later that you want to experience how the research world works, then you can apply to take time out of your training to do a research placement, as long as it is approved by the local governing body, the deanery. Is there anything about the job that you didn’t expect? I was surprised at the amount of networking. When you work on a specific area, a lot of people are doing related work so it’s good to build up a network of potential collaborators. One frustrating thing is the amount of bureaucracy involved to get all the approvals. If I worked for a large company, it would be someone’s job to sort it all out but I was doing lots of people’s jobs. Do you have any advice for medics who want to get into research? Don’t go in thinking it’s easy. From the sidelines, it can look that way when people see you walking around and talking to the patients. But that is just the tip of the iceberg – really, it’s not an 8 to 5 job and requires a lot of dedication. For example, if there is a serious adverse event, someone at the trial site will contact you at 2am and expect you to go in. You need a lot of self-discipline to get everything done on time. If you don’t have time management and organisational skills when you start, you’ll have to learn them very quickly! And if, like me, you are doing a placement, I think it is important to use this time wisely. Take time at the beginning to structure the three years, work out what your milestones are. Have you enjoyed it? Yes, very much. You get to go to lots of conferences, network and become an expert in your field. I find the research really, really fascinating. Although I plan to continue to specialise in clinical obstetrics and gynaecology, this experience means that if I wanted to work for a pharmaceutical company or a clinical research organisation, I could. It has opened a lot of doors. For more clinical research case studies, check out Alex Godwood, a biostatistician at MedImunne and Linda Murray, a CRA from the contract research organisation,